Officials with the FDA approved apalutamide (Erleada) for the treatment of patients with non-metastatic, castration-resistant prostate cancer, according to a press release.
Apalutamide is the first drug approved for non-metastatic, castration-resistant prostate cancer.
“In the trial supporting approval, Erleada had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public,” said Richard Pazdur, MD, director of the Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA Center for Drug Evaluation and Research.
The National Cancer Institute estimates that up to 20% of prostate cancers are castration-resistant and up to 16% of patients do not display evidence of metastasis until they are diagnosed as castration-resistant.
Apalutamide is an oral androgen receptor inhibitor that blocks the effect of androgens, such as testosterone, which are known to contribute to tumor growth.